Legislative framework of the Russian Federation. Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines - Rossiyskaya Gazeta 674 rules for destruction

In accordance with Articles 47 and 59 of the Federal Law "On Treatment medicines" Government of the Russian Federation decides:

Approve the attached Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines.

Chairman of the Government of the Russian Federation V. Putin

Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines

1. These Rules determine the procedure for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines, with the exception of issues related to the destruction of narcotic medicines and their precursors, psychotropic medicines and radiopharmaceutical medicines.

2. Substandard medicines and (or) falsified medicines are subject to seizure and destruction by decision of the owner of these medicines, decision Federal service for supervision in the field of healthcare and social development or a court decision.

3. The Federal Service for Surveillance in the Sphere of Healthcare and Social Development, in case of detection of facts of import into the territory of the Russian Federation or facts of circulation in the territory of the Russian Federation of substandard medicines and (or) counterfeit medicines, makes a decision obliging the owner of these medicines to carry out their seizure, destruction and removal to in full from the territory of the Russian Federation. This decision must contain:

a) information about medicines;

b) grounds for seizure and destruction of medicines;

c) the period for the seizure and destruction of medicines;

d) information about the owner of the medicines;

e) information about the manufacturer of medicines.

4. The owner of substandard medicines and (or) counterfeit medicines, within a period not exceeding 30 days from the date the Federal Service for Surveillance in Healthcare and Social Development made a decision on their seizure, destruction and export, is obliged to execute this decision or report his disagreement with him.

5. If the owner of substandard medicines and (or) falsified medicines does not agree with the decision on the seizure, destruction and export of these medicines, and also if he has not complied with this decision and has not reported measures taken, The Federal Service for Surveillance in Healthcare and Social Development is going to court.

6. Poor quality medicines and counterfeit medicines under customs regime destruction are subject to destruction in the manner established by customs legislation.

7. Substandard medicines, falsified medicines and counterfeit medicines are subject to destruction based on a court decision.

8. The destruction of substandard medicines, falsified medicines and counterfeit medicines is carried out by an organization that has a license to collect, use, neutralize, transport and dispose of waste of hazard class I - IV (hereinafter referred to as the organization carrying out the destruction of medicines), on special equipped sites, training grounds and in specially equipped premises in compliance with security requirements environment in accordance with the legislation of the Russian Federation.

9. Costs associated with the destruction of substandard medicines, counterfeit medicines and counterfeit medicines are reimbursed by their owner.

10. The owner of substandard medicines and (or) falsified medicines, who has made a decision to seize, destroy and export them, transfers these medicines to the organization carrying out the destruction of medicines on the basis of an appropriate agreement.

11. The organization carrying out the destruction of medicines draws up an act on the destruction of medicines, which indicates:

a) date and place of destruction of medicines;

b) last name, first name, patronymic of the persons who took part in the destruction of medicines, their place of work and position;

c) justification for the destruction of medicines;

d) information about destroyed medicines (name, dosage form, dosage, units of measurement, series) and their quantity, as well as containers or packaging;

e) name of the manufacturer of medicines;

f) information about the owner of the medicines;

g) method of destruction of medicines.

12. An act on the destruction of medicines is drawn up on the day of destruction of substandard medicines and (or) counterfeit medicines. The number of copies of this act is determined by the number of parties involved in the destruction of the specified medicinal products, signed by all persons who took part in the destruction of the specified medicinal products, and certified by the seal of the organization carrying out the destruction of the medicinal products.

13. The act on the destruction of medicines or its copy, certified in the prescribed manner, is sent by the owner of the destroyed medicines to the Federal Service for Surveillance in Healthcare and Social Development within 5 working days from the date of its preparation.

If the destruction of substandard medicines and (or) falsified medicines was carried out in the absence of the owner of the destroyed medicines, the act of destruction of medicines or its copy, certified in the prescribed manner, is sent within 5 working days from the date of its preparation by the organization carrying out the destruction medicines, their owner.

14. Control over the destruction of substandard medicines, counterfeit medicines and counterfeit medicines is carried out by the Federal Service for Surveillance in Healthcare and Social Development.

GOVERNMENT OF THE RUSSIAN FEDERATION

RESOLUTION

On approval of the Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines

____________________________________________________________________
Document with changes made:
Decree of the Government of the Russian Federation of September 4, 2012 N 882 (Collection of Legislation of the Russian Federation, N 37, 09/10/2012);
Decree of the Government of the Russian Federation of January 16, 2016 N 8 (Official Internet portal of legal information www.pravo.gov.ru, 01/19/2016, N 0001201601190006).
____________________________________________________________________

In accordance with Articles 47 and 59 of the Federal Law "On the Circulation of Medicines" the Government of the Russian Federation

decides:

Approve the attached Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines.

Chairman of the Government
Russian Federation
V.Putin

Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines

APPROVED
Government resolution
Russian Federation
dated September 3, 2010 N 674

1. These Rules determine the procedure for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines, with the exception of issues related to the destruction of narcotic medicines and their precursors, psychotropic medicines and radiopharmaceutical medicines.

2. Substandard medicines and (or) falsified medicines are subject to confiscation and destruction by decision of the owner of these medicines, the decision of the Federal Service for Surveillance in Healthcare in relation to medicines for medical use or the Federal Service for Veterinary and Phytosanitary Surveillance in relation to medicines for veterinary use(hereinafter referred to as the authorized body) or a court decision.

3. The authorized body, in the event of detection of facts of import into the territory of the Russian Federation or facts of circulation in the territory of the Russian Federation of substandard medicines and (or) counterfeit medicines, makes a decision obliging the owner of these medicines to carry out their seizure, destruction and removal in full from the territory Russian Federation. This decision must contain:

a) information about medicines;

b) grounds for seizure and destruction of medicines;

c) the period for the seizure and destruction of medicines;

d) information about the owner of the medicines;

e) information about the manufacturer of medicines.

4. The owner of substandard medicines and (or) counterfeit medicines, within a period not exceeding 30 days from the date the authorized body made a decision on their seizure, destruction and export, is obliged to execute this decision or report his disagreement with it.
(Clause as amended, put into effect on September 18, 2012 by Decree of the Government of the Russian Federation dated September 4, 2012 N 882; as amended by Decree of the Government of the Russian Federation dated January 16, 2016 N 8.

5. If the owner of substandard medicines and (or) falsified medicines does not agree with the decision on the seizure, destruction and export of these medicines, and also if he has not complied with this decision and has not reported on the measures taken, the authorized body goes to court .
(Clause as amended, put into effect on September 18, 2012 by Decree of the Government of the Russian Federation dated September 4, 2012 N 882; as amended by Decree of the Government of the Russian Federation dated January 16, 2016 N 8.

6. Substandard medicines and falsified medicines that are under the customs regime of destruction are subject to destruction in the manner established by customs legislation.

7. Substandard medicines, falsified medicines and counterfeit medicines are subject to destruction based on a court decision.

8. The destruction of substandard medicines, falsified medicines and counterfeit medicines is carried out by an organization that has a license to collect, use, neutralize, transport and dispose of waste of hazard class I-IV (hereinafter referred to as the organization carrying out the destruction of medicines), on special equipped sites, training grounds and in specially equipped premises in compliance with environmental protection requirements in accordance with the legislation of the Russian Federation.

9. Costs associated with the destruction of substandard medicines, counterfeit medicines and counterfeit medicines are reimbursed by their owner.

10. The owner of substandard medicines and (or) falsified medicines, who has made a decision to seize, destroy and export them, transfers these medicines to the organization carrying out the destruction of medicines on the basis of an appropriate agreement.

11. The organization carrying out the destruction of medicines draws up an act on the destruction of medicines, which indicates:

a) date and place of destruction of medicines;

b) last name, first name, patronymic of the persons who took part in the destruction of medicines, their place of work and position;

c) justification for the destruction of medicines;

d) information about the destroyed medicines (name, dosage form, dosage, units of measurement, series) and their quantity, as well as about the container or packaging;

e) name of the manufacturer of medicines;

f) information about the owner of the medicines;

g) method of destruction of medicines.

12. An act on the destruction of medicines is drawn up on the day of destruction of substandard medicines and (or) counterfeit medicines. The number of copies of this act is determined by the number of parties involved in the destruction of the specified medicinal products, signed by all persons who took part in the destruction of the specified medicinal products, and certified by the seal of the organization carrying out the destruction of the medicinal products.

13. The act on the destruction of medicines or its copy, certified in the prescribed manner, is sent by the owner of the destroyed medicines to the authorized body within 5 working days from the date of its preparation.
(Paragraph as amended, put into effect on September 18, 2012 by Decree of the Government of the Russian Federation dated September 4, 2012 N 882; as amended by Decree of the Government of the Russian Federation dated January 16, 2016 N 8.

If the destruction of substandard medicines and (or) falsified medicines was carried out in the absence of the owner of the destroyed medicines, the act of destruction of medicines or its copy, certified in the prescribed manner, is sent within 5 working days from the date of its preparation by the organization carrying out the destruction medicines, their owner.

14. Control over the destruction of substandard medicines, counterfeit medicines and counterfeit medicines is carried out by the authorized body.
(Clause as amended, put into effect on September 18, 2012 by Decree of the Government of the Russian Federation dated September 4, 2012 N 882; as amended by Decree of the Government of the Russian Federation dated January 16, 2016 N 8.

MINISTRY OF ENERGY OF THE RUSSIAN FEDERATION

ON APPROVAL OF STANDARDS

In accordance with paragraph 53 of the Rules for non-discriminatory access to transmission services electrical energy and the provision of these services, approved by Decree of the Government of the Russian Federation of December 27, 2004 N 861 (Collection of Legislation of the Russian Federation, 2004, N 52 (Part II), Art. 5525; 2007, N 14, Art. 1687; N 31, Art. 4100; 2009, N 25, Art. 3073; N 41, Art. 4771; 2010, N 12, Art. 1333; N 25, Art. 3175; 2012, N 23, Art. 3008; 2013, N 30 ( Part II), Art. 4119; N 31, Art. 4226; N 32, Art. 4309; N 35, Art. 4523; N 47, Art. 6105; 2014, N 7, Art. 689; N 9, Art. 913; N 11, Art. 1156; N 32, Art. 4513, Art. 4521), as well as the Methodology for determining standards for losses of electrical energy during its transmission through electric networks, approved by Order of the Ministry of Energy of Russia dated August 7, 2014 N 506 ( registered by the Ministry of Justice of Russia on September 17, 2014, registration N 34075), I order:

Approve the attached standards for losses of electrical energy during its transmission through electrical networks of territorial network organizations.

LOSSES OF ELECTRICAL ENERGY DURING ITS TRANSMISSION

BY ELECTRICAL NETWORKS OF TERRITORIAL

Supply of electrical energy to the electrical network / length of power lines in single-circuit terms, thousand kWh / km

Standards for losses of electrical energy during its transmission through electrical networks of territorial grid organizations from the supply of electrical energy to the electrical network, %

Order 674 dated 30092014

Order of the Ministry of Industry and Regional Development of the Pridnestrovian Moldavian Republic dated December 14, 2017 No. 674 “On introducing amendments and additions to the Order of the Ministry of Regional Development, Transport and Communications of the Pridnestrovian Moldavian Republic dated June 26, 2015 No. 78 “On entry into force regulatory documents on standardization in the territory of the Pridnestrovian Moldavian Republic" (publication in the newspaper "Transnistria" dated December 26, 2017 No. 239)

In accordance with the Decree of the Government of the Pridnestrovian Moldavian Republic of April 27, 2017 No. 87 “On approval of the Regulations, structure and maximum staffing levels of the Ministry of Industry and Regional Development of the Pridnestrovian Moldavian Republic” (SAZ 17-19), orders Yu:
1. Recognize the Order of the Ministry of Regional Development, Transport and Communications of the Pridnestrovian Moldavian Republic dated June 26, 2015 No. 78 “On the implementation of regulatory documents on standardization on the territory of the Pridnestrovian Moldavian Republic” as the Order of the Ministry of Industry and Regional Development of the Pridnestrovian Moldavian Republic.
2. Introduce the following addition to the Order of the Ministry of Regional Development, Transport and Communications of the Pridnestrovian Moldavian Republic dated June 26, 2015 No. 78 “On the implementation of regulatory documents on standardization on the territory of the Pridnestrovian Moldavian Republic”:
Subparagraph 10) of subparagraph a) of paragraph 1 of the Order is supplemented with subparagraph 10-1) with the following content:
“10-1) suspend paragraph 4.3 of GOST 31937-2011 “Buildings and structures. Rules for examination and monitoring technical condition».
Establish that the first inspection of the technical condition of buildings (structures) at hazardous production facilities in which technical devices (equipment) are located and (or) carried out technological processes, is carried out no later than 5 years after their commissioning, unless a different period is established in the regulatory and technical documentation for the building (structure). Subsequently, the inspection is carried out after the expiration of the standard service life, taken equal to 20 years after their commissioning, unless a different period is established in the regulatory and technical documentation for the building (structure), and then at intervals of at least once every 5 years.
Suspend clause 4.4 of GOST 31937-2011 “Buildings and structures. Rules for inspection and monitoring of technical condition" in terms of conducting an inspection after the expiration of the standard service life of buildings and structures."
2. State Unitary Enterprise “Institute of Technical Regulation and Metrology”, within two weeks, ensure that the information set out in paragraph 1 of this Order is brought to the attention of interested parties by publishing a message in the newspaper “Transnistria”.
3. This Order comes into force from the date of its signing.

minregion.gospmr.org

Form of the reverse side of the title page

This book contains numbered and laced _____ forms for

Application form

STATEMENT N _________

Form reverse side application form

Last name and initials of the applicant.

Measures taken upon application by the pharmacy administration

institution, store (branch) "Medtechnika".

Signature of the head of the pharmacy or store

19. The response was sent to the applicant » » .

19 g. For notes from the representative(s) of the pharmacy department

MRK, CRA of republican, regional, city administration

Date " " . 19 Position

to the Instructions on maintaining a book of complaints and suggestions in

pharmacies and Medtekhnika stores dealing

retail sale of medicines, items

medical purposes and medical equipment products

JOURNAL OF BOOKS OF COMPLAINTS AND SUGGESTIONS

(name of pharmacy department, MRK, CRA, republican
department "Medtechnika", regional, city department "Med-
technique")

date
issuance
books
and her
number

Name
institutions,
to whom you-
book given
complaints and
provisions

Schedule
ka in
semi-
understanding

Used book accepted

Numbers
and dates
acts
about uni-
What-
research institute
books

Order of the Minister of Defense of the Russian Federation dated October 18, 2016 N 674 “On amendments to the Procedure for providing monetary allowances to military personnel of the Armed Forces of the Russian Federation, approved by Order of the Minister of Defense of the Russian Federation dated December 30, 2011 N 2700 “On approval of the Procedure for providing monetary allowances to military personnel of the Armed Forces of the Russian Federation” Federation" (Registered with the Ministry of Justice of Russia on 09.11.2016 N 44272)

MINISTER OF DEFENSE OF THE RUSSIAN FEDERATION

ABOUT MAKING CHANGES

IN ORDER OF PROVIDING CASH ALLOWANCES TO MILITARY SERVANTS

OF THE ARMED FORCES OF THE RUSSIAN FEDERATION, APPROVED BY ORDER

2011 N 2700 “ON APPROVAL OF THE SECURITY PROCEDURE

CASH ALLOWANCES FOR MILITARY SERVANTS

FORCES OF THE RUSSIAN FEDERATION"

Introduce changes to the Procedure for providing monetary allowances to military personnel of the Armed Forces of the Russian Federation, approved by order of the Minister of Defense of the Russian Federation dated December 30, 2011 N 2700 “On approval of the Procedure for providing monetary allowances to military personnel of the Armed Forces of the Russian Federation” (registered with the Ministry of Justice of the Russian Federation on May 12, 2012 g., registration N 24125) (as amended by order of the Minister of Defense of the Russian Federation dated June 2, 2014 N 391 “On amendments to the Procedure for providing monetary allowances to military personnel of the Armed Forces of the Russian Federation, approved by order of the Minister of Defense of the Russian Federation dated December 30, 2011 No. 2700" (registered with the Ministry of Justice of the Russian Federation on August 11, 2014, registration No. 33536), according to the List (appendix to this order).

to the order of the Minister of Defense

CHANGES MADE IN THE PROCEDURE FOR PROVIDING CASH

SATISFACTION OF MILITARY SERVANTS OF THE RUSSIAN ARMED FORCES

FEDERATION, APPROVED BY ORDER OF THE MINISTER OF DEFENSE

In the Procedure for providing monetary allowances to military personnel of the Armed Forces of the Russian Federation (appendix to the order):

in the footnote ""***"" after the words "Art. 6336" add the words "; 2013, N 27, art. 3477; 2014, N 21, art. 2765; N 43, art. 5794; N 45, art. 6152; 2015, N 10, art. 1401; N 14, Art. 2008; 2016, N 27 (part II), art. 4238";

in paragraph eight, after the words “military medical institutions of the Ministry of Defense”, add the words “(except for federal budgetary (autonomous) institutions)”.

2. Add paragraph 4 with a second paragraph as follows:

“When a serviceman moves to a new place of military service, monetary allowance is paid for the full month in which the serviceman is excluded from the lists of personnel of the military unit (organization of the Armed Forces).”

3. In the footnote “”*”” to paragraph 18 after the words “Art. 5532" add the words "; 2012, N 2, art. 244; N 29, art. 4075; N 47, art. 6457; 2013, N 7, art. 633; N 13, art. 1526; 2014, N 8, art. 783; N 27, art. 3754; N 40 (part III), art. 5413; 2015, N 1 (part I), art. 199; N 13, art. 1909; N 18, Art. 2691; N 25, art. 3643; N 43, art. 5947; 2016, N 1 (part II), art. 216; N 32, art. 5096".

in the first paragraph after the words “military educational organizations higher education» add the words “by educational programs higher education";

add the following paragraph:

“For military personnel who have graduated from military educational organizations of higher education in secondary educational programs vocational education, in the period before taking on duties in military positions, salaries received by them on the day of graduation from the specified educational organizations are paid.”

5. In the first paragraph of paragraph 38, after the words “(handover of affairs and positions)”, add the words “and in the case of organizational and staffing measures - until the day of release from duties for the occupied (temporarily performed) military position (handover of affairs and positions) , but not later in the day the end of organizational and staffing activities specified in the legal act of the Ministry of Defense on the conduct of these organizational and staffing activities.”

6. In the footnote “”*”” to paragraph 41 after the words “Art. 7366" add the words "; 2012, N 50 (part IV), art. 6954; N 53 (part I), art. 7613; 2013, N 9, art. 870; N 13, Art. 1635; N 19, art. 2329, 2331; N 23, Art. 2869; N 27, art. 3462, 3477; N 48, art. 6165; 2014, N 11, art. 1094; N 14, Art. 1556; N 26 (part I), art. 3365; N 30 (part I), art. 4247; N 49 (part VI), art. 6923, 6924; N 52 (part I), art. 7542, 7544; 2015, N 13, art. 1802; N 17 (part IV), art. 2479; N 18, Art. 2628; N 27, art. 3963; N 29 (part I), art. 4356; N 41 (part I), art. 5628; 2016, N 7, art. 908; N 27 (part I), art. 4160, (part II), art. 4238".

7. In paragraph three of paragraph 42, replace the words “Air Forces” with the words “Aerospace Forces”.

8. Clause 44 is declared invalid.

after the words “on call” add the words “(Collected Legislation of the Russian Federation, 2012, No. 1, Art. 117; 2015, No. 11, Art. 1607; 2016, No. 31, Art. 5029)”;

words " Russian newspaper, 2011, No. 296" replace with the words "Collection of Legislation of the Russian Federation, 2012, No. 1, Art. 118; 2015, N 33, art. 4845";

b) paragraph six of subparagraph “e” should be stated as follows:

“in military positions of leaders, commanders (chiefs) of military units and organizations of the Armed Forces and their structural divisions, as well as in military positions, the performance of duties for which is related to the management of units, according to the list approved by the Minister of Defense of the Russian Federation;.”

10. In the second paragraph of paragraph 59, after the words “having the rank”, add the words “Instructor of parachute training.”

11. In the first paragraph of paragraph 94, after the words “in accordance with”, add the word “occupied”.

12. In paragraph 118:

in the footnote “”*”” the words “dated October 2, 2002 N 729 “On the amount of reimbursement of expenses associated with business trips on the territory of the Russian Federation to employees of organizations financed from the federal budget” (Collected Legislation of the Russian Federation, 2002, No. 40, Art. 3939),” deleted;

in paragraph two, replace the words “in the travel certificate” with the words “in the order of the corresponding commander (superior) on the trip.”

13. Paragraph four of paragraph 123 and the footnote “”*”” to it are considered invalid.

14. Paragraph 124 should be supplemented with the following paragraphs:

“In the event of the need for military personnel to stay in a hotel other than a hotel due to the conditions of their official assignment, payment for the costs of booking and renting residential premises (hereinafter referred to as accommodation) is made on the basis of the following documents confirming the amount of actual costs:

a) when living in the residential premises of an organization providing hotel services:

an invoice or other document from an organization providing hotel services confirming the actual costs of accommodation excluding cost additional services, certified by the established seal of this organization;

cash receipt for payment of services for accommodation, and when making payments without using cash register equipment- a document drawn up on a form strict reporting for making cash payments and (or) payments using payment cards;

b) when living in residential premises individual entrepreneur providing hotel services:

lease (sublease) agreement for residential premises indicating the amount of payment for residential premises and a copy of the certificate of state registration individual entrepreneur;

a cash receipt for payment for services for accommodation, and when making payments without the use of cash register equipment - a receipt cash order or a document drawn up on a strict reporting form for making cash payments and (or) payments using payment cards.

Accommodation outside hotels is issued by order official sending on a business trip."

15. In paragraph 125:

subparagraph “d” should be stated as follows:

“d) during departures of military personnel passing military service under contract, for preparation for entrance exams (exams) and passing entrance exams (exams):

to military professional educational organizations or military educational organizations of higher education, postgraduate studies, military doctoral studies and during the period of study in them;

to professional educational organizations, educational organizations of higher education with on-the-job training (by correspondence and part-time training) and during the period of training in them;";

subparagraph “d” shall be declared invalid;

the word “airfields,” shall be replaced with the words “airfields and (or)”;

after the words “military unit” add the words “defined in paragraph 58 of this Procedure.”

16. Paragraph 142 should be supplemented with subparagraph “m” with the following content:

“m) in connection with the loss of confidence in a serviceman in the cases provided for in subparagraphs “e.1” and “e.2” of paragraph 1 of Article 51 of the Federal Law of March 28, 1998 N 53-FZ “On Military Duty and Military Service” ."

17. In paragraphs four of paragraphs 170 and 173, after the words “not paid”, add the words “except for additional monthly payment military personnel undergoing military service on conscription, from among orphans and children left without parental care, paid in the manner provided for in paragraphs 75 - 76 of this Procedure.”

18. In the second paragraph of paragraph 185, delete the sign “*”” and the footnote to it.

19. Appendix No. 9 to the Procedure is declared invalid.

din 186 gost 13152

however, it is obvious that for the vast majority...

Order of the Ministry of Internal Affairs of Russia dated September 30, 2014 836 on the procedure for implementation

Here you can download Order of the Ministry of Internal Affairs of Russia dated September 30, 2014 836 on the procedure for implementation in fb2, txt, PDF, EPUB, doc, rtf, jar, djvu, lrf!

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  • GOVERNMENT OF THE RUSSIAN FEDERATION

    RESOLUTION

    ABOUT APPROVAL OF THE RULES

    In accordance with Articles 47 and 59 of the Federal Law "On the Circulation of Medicines", the Government of the Russian Federation decides:

    Approve the attached Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines.

    Chairman of the Government

    Russian Federation

    Approved

    Government Decree

    Russian Federation

    DESTRUCTION OF POOR-QUALITY MEDICINES,

    FALSE MEDICINES

    AND COUNTERFEIT MEDICINES

    1. These Rules determine the procedure for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines, with the exception of issues related to the destruction of narcotic medicines and their precursors, psychotropic medicines and radiopharmaceutical medicines.

    2. Substandard medicines and (or) counterfeit medicines are subject to seizure and destruction by decision of the owner of these medicines, a decision of the Federal Service for Surveillance in Healthcare in relation to medicines for medical use or the Federal Service for Veterinary and Phytosanitary Surveillance in relation to medicines for veterinary use (hereinafter referred to as the authorized body) or a court decision.

    3. The authorized body, in the event of detection of facts of import into the territory of the Russian Federation or facts of circulation in the territory of the Russian Federation of substandard medicines and (or) counterfeit medicines, makes a decision obliging the owner of these medicines to carry out their seizure, destruction and removal in full from the territory Russian Federation. This decision must contain:

    a) information about medicines;

    b) grounds for seizure and destruction of medicines;

    c) the period for the seizure and destruction of medicines;

    d) information about the owner of the medicines;

    e) information about the manufacturer of medicines.

    4. The owner of substandard medicines and (or) counterfeit medicines, within a period not exceeding 30 days from the date the authorized body made a decision on their seizure, destruction and export, is obliged to execute this decision or report his disagreement with it.

    5. If the owner of substandard medicines and (or) falsified medicines does not agree with the decision on the seizure, destruction and export of these medicines, and also if he has not complied with this decision and has not reported on the measures taken, the authorized body goes to court .

    6. Substandard medicines and falsified medicines that are under the customs regime of destruction are subject to destruction in the manner established by customs legislation.

    7. Substandard medicines, falsified medicines and counterfeit medicines are subject to destruction based on a court decision.

    8. The destruction of substandard medicines, falsified medicines and counterfeit medicines is carried out by an organization that has a license to collect, use, neutralize, transport and dispose of waste of hazard class I - IV (hereinafter referred to as the organization carrying out the destruction of medicines), on special equipped sites, training grounds and in specially equipped premises in compliance with environmental protection requirements in accordance with the legislation of the Russian Federation.

    9. Costs associated with the destruction of substandard medicines, counterfeit medicines and counterfeit medicines are reimbursed by their owner.

    10. The owner of substandard medicines and (or) falsified medicines, who has made a decision to seize, destroy and export them, transfers these medicines to the organization carrying out the destruction of medicines on the basis of an appropriate agreement.

    11. The organization carrying out the destruction of medicines draws up an act on the destruction of medicines, which indicates:

    a) date and place of destruction of medicines;

    b) last name, first name, patronymic of the persons who took part in the destruction of medicines, their place of work and position;

    c) justification for the destruction of medicines;

    d) information about the destroyed medicines (name, dosage form, dosage, units of measurement, series) and their quantity, as well as about the container or packaging;

    e) name of the manufacturer of medicines;

    f) information about the owner of the medicines;

    g) method of destruction of medicines.

    12. An act on the destruction of medicines is drawn up on the day of destruction of substandard medicines and (or) counterfeit medicines. The number of copies of this act is determined by the number of parties involved in the destruction of the specified medicinal products, signed by all persons who took part in the destruction of the specified medicinal products, and certified by the seal of the organization carrying out the destruction of the medicinal products.

    13. The act on the destruction of medicines or its copy, certified in the prescribed manner, is sent by the owner of the destroyed medicines to the authorized body within 5 working days from the date of its preparation.

    If the destruction of substandard medicines and (or) falsified medicines was carried out in the absence of the owner of the destroyed medicines, the act of destruction of medicines or its copy, certified in the prescribed manner, is sent within 5 working days from the date of its preparation by the organization carrying out the destruction medicines, their owner.

    14. Control over the destruction of substandard medicines, counterfeit medicines and counterfeit medicines is carried out by the authorized body.

    GOVERNMENT OF THE RUSSIAN FEDERATION

    RESOLUTION

    dated June 3, 2017 No. 674

    MOSCOW

    On approval of the Rules for the provision of subsidies from the federal budget to Russian credit organizations to compensate for lost income on loans issued in 2017 to small and medium-sized businesses at a preferential rate

    The Government of the Russian Federation decides:

    1. Approve the attached Rules for the provision of subsidies from the federal budget to Russian credit organizations to compensate for lost income on loans issued in 2017 to small and medium-sized businesses at a preferential rate.

    2. Financial support for the fulfillment of expenditure obligations for the provision of subsidies in accordance with the Rules approved by this resolution is carried out at the expense of budgetary allocations provided for in the federal law on the federal budget for the corresponding fiscal year and planning period. (As amended by Decree of the Government of the Russian Federation dated April 13, 2019 No. 451)

    Chairman of the Government

    Russian Federation D. Medvedev

    RULES for the provision of subsidies from the federal budget to Russian credit organizations to compensate for lost income on loans issued in 2017 to small and medium-sized businesses at a preferential rate

    (As amended by Decrees of the Government of the Russian Federation dated December 15, 2017 No. 1561, dated April 13, 2019 No. 451)

    1. These Rules establish the goals, conditions and procedure for providing subsidies from the federal budget to Russian credit organizations to compensate for lost income on loans issued in 2017 to small and medium-sized businesses at a preferential rate (hereinafter referred to as borrowers, loans, subsidies, respectively).

    2. Subsidies are provided based on a preferential rate of no more than 9.6 percent per annum for the borrower (provided that the borrower is a medium-sized business entity) or no more than 10.6 percent per annum (provided that the borrower is a small business entity), under loan agreements, taking into account the restrictions on the period for concluding a loan agreement provided for by these Rules, and the limits on funds for issuing loans to borrowers (hereinafter referred to as the funds limits) established for Russian credit organizations.

    3. Subsidies are provided monthly by the Ministry economic development of the Russian Federation within the limits of budgetary allocations provided for in the federal law on the federal budget for the corresponding financial year and planning period, and limits budget obligations, communicated in the prescribed manner to the Ministry of Economic Development of the Russian Federation as the recipient of federal budget funds for the purposes provided for by these Rules. (As amended by Decree of the Government of the Russian Federation dated December 15, 2017 No. 1561)

    4. Concepts used in these Rules:

    "authorized bank" is a Russian credit organization that is economic company, in the authorized capital of which the share of participation of the Russian Federation or the Central Bank of the Russian Federation exceeds 50 percent, the amount of equity (capital) of which (calculated according to the methodology of the Central Bank of the Russian Federation) is at least 300 billion rubles (as of the last reporting date), selected in accordance with these Rules;

    “loan agreement (agreement)” - a loan agreement under which an authorized bank provides a loan to the borrower, taking into account the restrictions on the period for concluding the loan agreement and the limit of funds provided for by these Rules;

    “register of borrowers” ​​- a register of borrowers who have entered into loan agreements (agreements) formed by an authorized bank in the current financial year in the form according to Appendix No. 1.

    5. In order to provide subsidies, the Ministry of Economic Development of the Russian Federation forms a commission on the provision of subsidies (hereinafter referred to as the commission) and approves its composition.

    6. The commission performs the following functions:

    a) considers applications from Russian credit institutions and the documents attached to them for receiving subsidies, submitted in accordance with paragraph 21 of these Rules, approves the list of authorized banks and decides to establish a limit of funds for authorized banks or to refuse a limit of funds, and also coordinates plans -schedules for the monthly issuance of loans to borrowers by authorized banks, which may involve experts in the work;

    b) considers the applications of authorized banks and the documents attached to them for receiving subsidies, submitted in accordance with paragraph 32 of these Rules, and makes a decision to provide a subsidy or to refuse to provide it. The commission has the right to involve experts in its work;

    c) performs other functions and makes other decisions provided for by these Rules. (Added - Decree of the Government of the Russian Federation dated April 13, 2019 No. 451)

    7. Meetings of the commission are held as necessary by the chairman of the commission, and in his absence - by the deputy chairman of the commission (hereinafter referred to as the chairman of the meeting). Meetings of the commission are considered valid if more than half of its members are present. Meetings of the commission can be organized in absentia. However, voting by proxy is not permitted.

    8. Decisions of the commission are made by open voting by a simple majority of votes of the members of the commission present at the meeting. When voting, each member of the commission has one vote. In case of equality of votes, the decision voted for by the chairman of the meeting is considered adopted. In case of disagreement with by decision a member of the commission has the right to express his opinion in writing.

    9. Based on the results of consideration of issues at commission meetings, decisions are made, which are documented in minutes. The minutes of the meetings are signed by the chairman of the meeting and the secretary of the commission. The opinions of the commission members (if any) expressed in writing are subject to mandatory inclusion in the minutes of the commission meeting.

    10. The secretary of the commission no later than 5 working days before the meeting of the commission notifies the members of the commission about the holding of its meeting, prepares materials for the meetings of the commission, keeps minutes of the meetings of the commission, brings the decisions of the commission to the attention of interested parties and monitors the implementation of the decisions of the commission, and also signs extracts from the minutes of commission meetings.

    11. Information, analytical, organizational and technical support for the commission’s activities is provided by the Ministry of Economic Development of the Russian Federation with the participation joint stock company"Federal Corporation for the Development of Small and Medium Enterprises."

    12. The selection of Russian credit organizations as authorized banks is carried out by a commission. The criteria for selecting a Russian credit organization as an authorized bank are:

    a) the share of participation of the Russian Federation or the Central Bank of the Russian Federation in the authorized capital of a Russian credit organization exceeding 50 percent;

    b) the amount of equity (capital), calculated according to the methodology of the Central Bank of the Russian Federation, amounting to at least 300 billion rubles (as of the last reporting date);

    c) compliance with the mandatory standards established by the Central Bank of the Russian Federation on the first day of the month preceding the month in which the application for selection is submitted;

    d) on the first day of the month preceding the month in which the application for selection is submitted, a Russian credit institution:

    does not have an unfulfilled obligation to pay taxes, fees, insurance premiums, penalties, fines and interest payable in accordance with the legislation of the Russian Federation on taxes and fees;

    has no overdue debt for the return of subsidies to the federal budget, budget investments provided from the federal budget, including in accordance with other legal acts of the Russian Federation, and other overdue debt to the federal budget; (As amended by Decree of the Government of the Russian Federation dated December 15, 2017 No. 1561)

    is not in the process of reorganization, liquidation or bankruptcy; (As amended by Decree of the Government of the Russian Federation dated December 15, 2017 No. 1561)

    is not a foreign legal entity, as well as a Russian legal entity, in the authorized (share) capital of which there is a share of participation of foreign legal entities, the place of registration of which is a state or territory included in the list of states and territories that provide preferential tax treatment, approved by the Ministry of Finance of the Russian Federation and (or) not providing for the disclosure and provision of information when conducting financial transactions (offshore zones) in relation to such legal entities, in total exceeds 50 percent;

    does not receive funds from the federal budget on the basis of other regulatory legal acts or municipal legal acts for the purposes specified in paragraph 1 of these Rules.

    13. The notice of acceptance of documents from Russian credit institutions for selection is posted on the official website of the Ministry of Economic Development of the Russian Federation on the Internet information and telecommunications network and contains:

    a) name and address of the Ministry of Economic Development of the Russian Federation;

    b) reception address, date, start and end time of accepting documents from Russian credit institutions;

    c) contact information of the Ministry of Economic Development of the Russian Federation (telephone numbers, email addresses).

    14. Subsidies are provided to authorized banks, and in the case provided for in paragraph four of clause 361 of these Rules, also to Russian credit organizations in accordance with the loan agreements (agreements) concluded with the borrower, following conditions: (As amended by Decree of the Government of the Russian Federation dated April 13, 2019 No. 451)

    a) the loan agreement (agreement) was concluded during the period from January 1 to August 1, 2017, and the goals of the loan provided must correspond to the goals of the program for stimulating lending to small and medium-sized businesses, which provides for the provision of loans to authorized banks from the Central Bank of the Russian Federation, secured by guarantees of a joint stock company Society "Federal Corporation for the Development of Small and Medium Enterprises" (hereinafter referred to as the program);

    the interest rate on the loan should be for the borrower no more than 9.6 percent per annum (provided that the borrower is a medium-sized business entity) or no more than 10.6 percent per annum (provided that the borrower is a small business entity);

    the borrower with whom the authorized bank has concluded a loan agreement (agreement) must comply with the requirements provided for in paragraph 17 of these Rules;

    the size of one loan provided to the borrower must be no less than 5 million rubles and no more than 1 billion rubles. At the same time, the total volume of loans that can be issued to one borrower by one or more authorized banks cannot exceed 4 billion rubles;

    the loan agreement (agreement) provides for the borrower to receive a loan in rubles;

    the term of the loan agreement (agreement) concluded with the borrower is no more than 15 years;

    b) the loan agreement (agreement) was concluded during the period from August 1 to December 31, 2017, and the purposes of providing the loan are the implementation of investment projects, the acquisition or creation of fixed assets, including construction, modernization of capital construction projects, including engineering surveys , preparation of project documentation, and the conditions provided for in paragraphs two to six of subparagraph “a” of this paragraph are met.

    (Clause as amended by Decree of the Government of the Russian Federation dated December 15, 2017 No. 1561)

    15. The amount of the subsidy under credit agreements (agreements) specified in subparagraph “a” of paragraph 14 of these Rules and providing for the provision of a revolving credit line or a credit line with a debt limit to the borrower cannot exceed the amount calculated based on the volume of credit funds actually issued in 2017 year, as well as the size specified in paragraph six of subparagraph “a” of paragraph 14 of these Rules.

    Subsidizing under loan agreements (agreements) specified in paragraph one of this paragraph, in terms of loan tranches issued after December 31, 2017, is not provided.

    16. Providing subsidies to authorized banks under loan agreements (agreements) that were refinanced by providing authorized banks with loans from the Central Bank of the Russian Federation, secured by guarantees from the joint stock company "Federal Corporation for the Development of Small and Medium Enterprises" within the framework of the program, is not allowed.

    17. The borrower must meet the following requirements:

    a) be a small or medium-sized business entity and not belong to the small and medium-sized business entities specified in parts 3 and 4 of Article 14 of the Federal Law “On the Development of Small and Medium-Sized Businesses in the Russian Federation”;

    b) carry out activities in one or more sectors of the economy according to the list in accordance with Appendix No. 2;

    c) have the status of a tax resident of the Russian Federation;

    d) insolvency (bankruptcy) proceedings should not be initiated against the borrower in accordance with the legislation of the Russian Federation on insolvency (bankruptcy);

    e) have no overdue (unsettled) debts on taxes, fees and other obligatory payments to budgets budget system Russian Federation;

    f) have no debts to employees (personnel) for wages;

    g) not, during a period of 180 calendar days preceding the date of the authorized bank’s decision to provide a loan to the final borrower, be overdue for a period of more than 30 months; calendar days payments for servicing the loan portfolio (positive credit history).

    18. The borrower independently selects an authorized bank to receive a loan. The authorized bank considers the possibility of providing a loan in accordance with the rules and procedures adopted by the authorized bank.

    19. The borrower applying for a loan submits documents to the authorized bank in accordance with the requirements of these Rules and the authorized bank. The verification of borrowers' compliance with the requirements specified in paragraph 17 of these Rules, as well as the intended use of the loan, is carried out by an authorized bank on the basis of documents submitted by the borrower.

    20. Credit funds provided by an authorized bank to a borrower in accordance with a loan agreement (agreement) cannot be placed on deposits, as well as in other financial instruments.

    21. In order to participate in the selection for a subsidy and calculate the limits of funds, authorized banks, within 10 calendar days from the date of posting the notice specified in paragraph 13 of these Rules, submit an application to the Ministry of Economic Development of the Russian Federation in the form according to Appendix No. 3 (hereinafter - application), to which the following documents are attached:

    a) a preliminary schedule for the monthly issuance of loans to borrowers authorized by the bank;

    b) information about the state registration of the Russian credit organization as legal entity and a copy of the banking license issued by the Central Bank of the Russian Federation;

    c) notarized copies constituent documents Russian credit organization;

    d) a certificate signed by the head and chief accountant of a Russian credit organization, sealed (if available), indicating bank details and accounts to which the subsidy should be transferred.

    22. Ministry of Economic Development of the Russian Federation:

    a) registers in order of priority the applications and the documents attached to them, specified in paragraph 21 of these Rules;

    b) checks within 15 working days from the date of receipt of applications the completeness of the information contained in them and the completeness of the submitted documents, calculates the limit of funds for authorized banks in accordance with paragraph 23 of these Rules, adjusts the schedule for the monthly issuance of loans to borrowers by authorized banks (hereinafter referred to as the plan -schedule) in accordance with the approved funds limits and submits them for consideration by the commission;

    c) approves, based on the decision of the commission, the list of authorized banks and the limits of funds for authorized banks;

    d) sends a notification to the authorized bank about the amount of the funds limit in the form in accordance with Appendix No. 4 or about the refusal of the funds limit.

    23. The limit of funds for the authorized bank (C) is determined by the formula:

    C = (Vi / Vtotal) x Z,

    Vi is the volume of loans issued to borrowers by an authorized bank for the period from December 1, 2015 to March 1, 2017 under the program;

    Vtot. - the total volume of loans issued to borrowers by authorized banks for the period from December 1, 2015 to March 1, 2017 under the program;

    Z - total limit of funds equal to 50 billion rubles.

    24. The limit of funds for one authorized bank cannot exceed 50 percent of the total limit of funds equal to 50 billion rubles, that is, 25 billion rubles. If the limit of funds calculated in accordance with paragraph 23 of these Rules amounts to more than 25 billion rubles, the amount in excess of 25 billion rubles is evenly redistributed among other authorized banks.

    25. Overall size subsidies for an authorized bank (Si) are determined by the formula:

    Si = Ci / 500,000 million rubles x S,

    Ci is the limit of funds for the authorized bank;

    S - the total volume of budgetary allocations provided for federal law on the federal budget for the corresponding financial year and planning period, within the limits of budget obligations communicated in the prescribed manner to the Ministry of Economic Development of the Russian Federation as the recipient of federal budget funds for the purposes specified in paragraph 1 of these Rules. (As amended by Decree of the Government of the Russian Federation dated December 15, 2017 No. 1561)

    26. Authorized banks issue loans to borrowers on a monthly basis in accordance with the schedule.

    If an authorized bank issues loans in an amount less than the amount specified in the schedule for 2 months in a row, the commission proportionally redistributes the amount of the limit of funds established for the authorized bank among other authorized banks that previously had a limit of funds, subject to applications from authorized banks on consent to increase the funds limit.

    The issuance of loans by an authorized bank in an amount less than the amount specified in the schedule is not grounds for termination of the subsidy.

    27. The subsidy is provided to the authorized bank on the basis of a subsidy agreement concluded between the authorized bank and the Ministry of Economic Development of the Russian Federation (hereinafter referred to as the subsidy agreement) under standard form, approved by the Ministry of Finance of the Russian Federation.

    If the commission decides to redistribute